FDA Medical Device Recalls (openFDA)
Orthosoft, Inc. dba Zimmer CAS: Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
- Recall number
- Z-1881-2017
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Product
- Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
- Status
- Terminated
- Initiated
- 2011-10-06
- Posted
- 2017-04-26
- Terminated
- 2017-05-08
- Reason
- Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
- Root cause
- Software design
- Action
- Zimmer sent a Medical Device Field Notification letter dated December 6, 2011, to all affected customers. This is a retrospective report of a correction taken on 6 December 2011. The software issues were fixed in the new software version 2.3.3.0. Recall notices were distributed on December 6, 2011. Telephone: 18663367846 (US & Canada) or 5143958883 (International), Email: cassupport@zimmercas.com Customers with questions should call 1-866-336-7846 (US & Canada) 514-395-8883 (International). For questions regarding this recall call 574-372-4487.
- Quantity
- 105
- Distribution
- Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
- Lot, serial or model codes
- Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
- 510(k) numbers
- ["K110054"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3003714383
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28